Drug product
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
D-0573-2020
Product summary
- Event
- Event 84241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,850 vials
- Official record key
drug-enforcement:D-0573-2020
Official wording
Reason: Presence of Foreign Substance: Foreign material found inside the vial.
Code information: Batch #: CLC190049, Exp 02/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance